OmniTrans Transport System
FDA 510(k) clearance K240235 · decided 2024-08-19
Clearance details
- K-number
- K240235
- Device name
- OmniTrans Transport System
- Applicant
- Shenzhen Dakewe Bio-Engineering Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-29
- Decision date
- 2024-08-19
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- JSM
- Device class
- 1
- Regulation number
- 866.2390
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.